What Aquestive Therapeutics does

Aquestive Therapeutics is a US specialty pharmaceutical company that develops, manufactures, and commercializes medicines using two proprietary drug delivery platforms. The PharmFilm platform delivers active pharmaceutical ingredients via dissolvable sublingual, buccal, and lingual films and has supported over 2.5 billion doses shipped worldwide across products available on six continents. The AdrenaVerse platform is a proprietary library of more than 20 epinephrine prodrugs with patent protection extending to 2037, enabling controlled epinephrine absorption across mucosal and dermal dosage forms including lotions, creams, and ointments.

The company's commercial revenue comes from three streams: (1) licensing and royalties on four FDA-approved products commercialized by partners — Sympazan (Assertio Holdings), Suboxone (Indivior), Emylif (Zambon UK), and Ondif (Hypera Pharma SA); (2) a CDMO (Contract Development and Manufacturing Organization) business offering FDA-compliant, DEA-registered manufacturing and DSCSA-serialized packaging at two Indiana facilities totaling 34,400+ square feet; and (3) planned direct commercialization of its proprietary pipeline assets Anaphylm (dibutepinephrine sublingual film for anaphylaxis) and Libervant (diazepam buccal film for seizure clusters). The Anaphylm NDA received a Complete Response Letter from the FDA in January 2026 citing human factors and packaging deficiencies, and the company plans a Q3 2026 resubmission. Aquestive employs 101–250 people, is headquartered in Warren, New Jersey, and trades on NASDAQ as AQST following its 2018 IPO.

Name

Aquestive Therapeutics

Legal name

Aquestive Therapeutics, Inc.

Website

https://aquestive.com

Company type

Public

Founded year

2005

Operating status

Operating

Headcount range

101–250 employees

Short description

Aquestive Therapeutics is a US specialty pharmaceutical company that develops and manufactures proprietary oral film (PharmFilm) and epinephrine prodrug (AdrenaVerse) drug delivery technologies, licensing FDA-approved products to pharma partners and operating a CDMO services business, with a pipeline led by Anaphylm for anaphylaxis.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Oral film drug delivery
• Specialty pharmaceutical products
• Pharmaceutical CDMO services
• Epinephrine delivery systems
• Sublingual buccal film technology

Headquarters

HQ city

Warren

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Supply Chain, Infrastructure, Marketing or Sales

Revenue model

1. Product Licensing & Royalty Revenue: Aquestive licenses its PharmFilm technology and proprietary products to pharmaceutical companies. Revenue is generated through licensing fees, milestone payments, and ongoing royalties on net sales of licensed products. Four products are currently commercialized by licensees: Sympazan (Assertio Holdings), Suboxone (Indivior), Emylif (Zambon UK Limited), and Ondif (Hypera Pharma SA).
2. CDMO Manufacturing & Packaging Services: Aquestive operates as a Contract Development and Manufacturing Organization (CDMO), providing FDA-compliant manufacturing and packaging services for pharmaceutical, OTC, and wellness products. Services include oral film production, topical/liquid packaging, serialization, and regulatory support. Revenue is generated through service fees for development, manufacturing, and packaging of client products.
3. Proprietary Product Commercialization: Upon FDA approval of Anaphylm (dibutepinephrine sublingual film) and Libervant (diazepam buccal film), Aquestive plans to commercialize these proprietary products directly or through co-promotion agreements. Revenue will be generated through product sales. The company has built out commercial infrastructure including a Chief Commercial Officer and is preparing for launch.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Aquestive Therapeutics is a specialty pharmaceutical company that develops, licenses, and manufactures pharmaceutical products using its proprietary PharmFilm oral film drug delivery technology and AdrenaVerse epinephrine prodrug platform. The company generates revenue through licensing its technology and FDA-approved products to pharmaceutical partners (Sympazan, Suboxone, Emylif, Ondif), providing CDMO manufacturing and packaging services to third-party brands, and advancing a proprietary pipeline (Anaphylm, Libervant, AQST-108) toward direct commercialization.

Product overview

Aquestive Therapeutics is a pharmaceutical company advancing medicines through innovative drug delivery technologies. The company's portfolio centers on two proprietary technology platforms: PharmFilm, a proven oral film drug delivery system enabling sublingual, buccal, and lingual administration; and AdrenaVerse, a novel epinephrine prodrug platform for localized delivery. The pipeline includes Anaphylm (dibutepinephrine sublingual film) for severe allergic reactions and Libervant (diazepam buccal film) for seizure clusters, both leveraging PharmFilm technology. The company commercializes multiple FDA-approved products through licensees including Sympazan, Suboxone, Emylif, and Ondif. Beyond proprietary products, Aquestive operates a contract development and manufacturing (CDMO) business offering pharmaceutical manufacturing and packaging services.

Differentiator

Problem solved

Functional benefit

Brands

• PharmFilm: Proprietary oral film drug delivery technology platform enabling precise dosing through buccal, sublingual, and lingual film options.
• AdrenaVerse
• Anaphylm
• Libervant

Products and services

• Anaphylm (dibutepinephrine) Sublingual Film First orally delivered film formulation of epinephrine in clinical development for emergency treatment of severe allergic reactions including anaphylaxis. Developed using PharmFilm and AdrenaVerse technologies, designed for rapid non-invasive epinephrine delivery without injection.
• Libervant (diazepam) Buccal Film First and only orally-administered, non-device diazepam product candidate for treatment of seizure clusters in children ages 2-5 years and patients 12 and older. Discreet, mint-flavored dissolving film delivered using PharmFilm technology.
• AQST-108 (epinephrine) Topical Gel Epinephrine topical gel product candidate using AdrenaVerse platform technology for potential multiple indications in dermatology.
• PharmFilm Technology Platform (Licensed) Proprietary drug delivery platform enabling precise oral delivery of active pharmaceutical ingredients through small dissolvable films without water or swallowing. Supports sublingual, buccal, and lingual administration routes. Licensed to pharmaceutical companies for use in their commercialized products.
• AdrenaVerse Technology Platform (Licensed) Proprietary prodrug platform containing library of over 20 epinephrine prodrugs enabling localized, sustained epinephrine delivery across mucosal and dermal surfaces through lotions, creams, and ointments. Patent protection through 2037.
• Sympazan (clobazam) Oral Film FDA-approved oral film formulation of clobazam commercialized by Assertio Holdings using Aquestive's PharmFilm technology for treatment of seizures.
• Suboxone (buprenorphine and naloxone) Sublingual Film FDA-approved sublingual film formulation commercialized by Indivior Inc. using PharmFilm technology for opioid dependence treatment.
• Emylif (riluzole) Film Orodispersible FDA-approved riluzole film orodispersible product commercialized by Zambon UK Limited using Aquestive's PharmFilm technology for ALS treatment.
• Ondif (ondansetron) Oral Film Ondansetron orodisposable film product commercialized by Hypera Pharma SA using Aquestive's PharmFilm technology for nausea and vomiting treatment.
• CDMO Contract Manufacturing Services Full-scale FDA-compliant contract manufacturing services including oral film production (2.5+ billion doses produced), clinical to commercial scale, cGMP manufacturing, QA/QC, and controlled substance handling with DEA registration. Two Indiana facilities totaling 34,400+ ft² of GMP space serving pharmaceutical, OTC, and wellness brand clients.
• Packaging Services High-throughput US-based packaging and serialization services for liquid, creams, topicals, gels, semi-solids, and oral film products. Fully DSCSA-compliant serialized packaging with artwork, labeling, and final assembly support.

Quantifiable outcome

• Over 2.5 billion PharmFilm doses shipped worldwide
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Assertio Holdings, Inc.coreOEM/ Whitelabel/ Licensing PartnerAssertio Holdings commercializes Sympazan (clobazam) oral film, an FDA-approved product utilizing Aquestive's PharmFilm technology. This is a licensing arrangement where Aquestive's technology is embedded in a commercialized pharmaceutical product.
• Indivior, Inc.coreOEM/ Whitelabel/ Licensing PartnerIndivior commercializes Suboxone (buprenorphine and naloxone) sublingual film, an FDA-approved product utilizing Aquestive's PharmFilm technology. Suboxone was one of Aquestive's first two FDA-approved products in 2010.
• Zambon UK LimitedminorOEM/ Whitelabel/ Licensing PartnerZambon UK Limited commercializes Emylif (riluzole) film orodispersible, an FDA-approved product utilizing Aquestive's PharmFilm technology for ALS treatment.
• Hypera Pharma SAminorOEM/ Whitelabel/ Licensing PartnerHypera Pharma SA commercializes Ondif (ondansetron) orodisposable film utilizing Aquestive's PharmFilm technology for nausea and vomiting treatment.

Scale indicators8 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• IntelGenx Technologies: IntelGenx is a specialty drug delivery company built around proprietary oral thin film technology, with a business model combining proprietary product development (similar to Aquestive's Anaphylm/Libervant pipeline) and CDMO/licensing partnerships (similar to Aquestive's Sympazan/Suboxone licensees). Both companies focus on transforming approved APIs into differentiated film-based dosage forms for partners.
• LTS Lohmann Therapie-Systeme: LTS is a global leader in transdermal and oral thin film drug delivery systems, operating both proprietary development and contract development/manufacturing (CDMO) businesses. It is one of the most direct comparables to Aquestive's combined platform-plus-CDMO model and competes for similar pharmaceutical licensing partnerships.

Broad incumbents

• Catalent: Catalent is a large, publicly traded global CDMO offering oral, injectable, and other drug delivery capabilities across a broad portfolio. While not specialized in oral thin films like Aquestive, Catalent competes for the same pharmaceutical CDMO customers and licensing partnerships and represents the scaled incumbent benchmark for the CDMO segment of Aquestive's business.
• Viatris: Viatris owns the EpiPen franchise, the dominant injectable epinephrine rescue therapy and the direct competitive incumbent for Aquestive's Anaphylm. Viatris also licenses Suboxone sublingual film from Aquestive via its Indivior relationship history and is a critical reference point for assessing Anaphylm's addressable market and switching dynamics.
• Collegium Pharmaceutical: Collegium is a specialty pharma focused on pain and CNS indications with a portfolio that includes film-based and abuse-deterrent products. Its specialty commercial model and CNS/pain therapeutic focus overlap meaningfully with Aquestive's planned direct commercialization of Libervant and CNS pipeline ambitions.

Emerging players

• Neurelis: Neurelis developed Valtoco, a diazepam nasal spray approved for seizure clusters, positioning it as a direct therapeutic-area competitor to Aquestive's Libervant (diazepam buccal film). Both target the same patient population (seizure clusters in epilepsy) with non-injectable, non-rectal delivery alternatives and compete for similar neurology specialist and pediatric prescribing relationships.
• BioDelivery Sciences International: BioDelivery Sciences (now part of Collegium Pharmaceutical) was a specialty pharma that commercialized film-based and buccal opioid products using its proprietary drug delivery platform. Its model of licensing and direct commercialization of differentiated formulations in CNS/pain indications is highly comparable to Aquestive's license-and-pipeline strategy.
• Eagle Pharmaceuticals: Eagle Pharmaceuticals is a small-cap specialty pharma that develops and commercializes differentiated formulations of existing molecules, often through partnerships. Its specialty commercial infrastructure, small molecule reformulation focus, and reliance on licensing partners place it in a similar size and business model tier to Aquestive.
• Tapemark: Tapemark is a private contract manufacturer specializing in transdermal patches and oral thin film drug delivery. It competes directly with Aquestive's CDMO segment for pharmaceutical and OTC brand customers seeking US-based film manufacturing capabilities, and its scale and capabilities are a useful comparator for that segment of Aquestive's business.

Others

• Assertio Holdings: Assertio is the licensee that commercializes Aquestive's Sympazan (clobazam oral film) and also markets other specialty neurology products. As a direct commercial partner and adjacent specialty pharma operator, Assertio provides useful comparability for the economics and execution requirements of Aquestive's licensee model.

Market position

Strengths1 record

Weaknesses1 record

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/aquestive
• Xx.com/aquestive

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds13 records

Investors14 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Aquestive Therapeutics